63 results
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…
Period 1:The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with active RA who are on a stable dose of conventional synthetic disease-…
Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…
To assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer*s disease-causing mutation by determining if treatment with the study drug slows the rate of progression…
The primary objective of this study is to evaluate the effect of inclisiran treatment on:*LDL-C levels at Day 510*Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levelsThe secondary objectives of this study are…
The primary objective is to confirm that bronchodilator monotherapy (tiotropium) plus behavioural modification, bronchodilator combination therapy (tiotropium + olodaterol FDC) plus behavioural modification, and bronchodilator combination therapy (…
It is expected that LF111 will offer benefits to adults in the form of efficacy similar to COCPs, absence of estrogen-related risks, reduced tendency to weight gain and extended dosing window. It is likely that adolescents will share these benefits…
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein (LDL) cholesterol (LDL-C) by REGN727 in comparison with ezetimibe (EZE) 10 mg PO QD after 24 weeks in patients with primary hypercholesterolemia (…
The aim of the study is to show that a therapy based on a thrice weekly administration (i.e. at each HD session) of vitamin K1 for a period of 18 months attenuates the progression of coronary artery and thoracic aortic calcifications compared to…
To assess the safety of lengthening the adalimumab dosing interval from 2 to 3 weeks, in patients with Crohn*s disease or ulcerative colitis in long term (6 months) remission.
To compare the effect of IT dexamethasone versus IT gentamicin on number and severity vertigo attacks.To compare the effects of IT dexamethasone with IT gentamicin on hearing function, functional level scale and aural fullness.
Primary ObjectiveTo demonstrate that the effectiveness of the NOVOCART® 3D plus autologouschondrocyte transplantation system is superior to microfracture for the treatment ofarticular cartilage defects of the knee by demonstrating superiority of the…
1. Is KJD clinically non-inferior to current surgical techniques (HTO and TKP)?2. Is KJD superior to HTO in actual structural repair of cartilage?3. Is KJD cost-effective in the long-term compared to HTO and TKP?
To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…
The goal of the proposed study is to build knowledge about the effect of Naltrexone in a regular sample of cannabis addicts in a mid-size town. To accomplish this, we propose to: a) do a double blind randomized controlled trial with Naltrexone in…
The first objective of this study is whether DCS addition to exposure therapy enhances symptom reduction in PD+AGO. The second objective of the study is to establish the optimal timing of administration of D-cycloserine (directly pre- or post…
To establish the efficacy of 60 mg baclofen compared to placebo in inducing a decrease in food craving, as assessed by a food craving questionnaires (G-FCQ-T) over 6 months in obese subjects.
The primary objective of this study is to demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004% (preserved with POLYQUAD) is noninferior to Timolol Ophthalmic Solution (0.5% or 0.25%) in pediatric glaucoma patients.
To determine the efficacy and the safety of PREOB, a proprietary population of autologous bone-forming cells, in the treatment of non-infected hypotrophic non-union fractures of long bones.